EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/1195/2022 
(POOL/E4/2022/1195/1195 -EN.docx)  
[…](2022) XXX  draft 
 
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving 1,2 -benzisothiazol -3(2H) -one (BIT) as an active substance for use in 
biocidal products of product -type 10 in accordance with Regulation (EU) No 528/2012 of 
the European Parliament and of the Council  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving 1,2 -benzisothiazol -3(2H) -one (BIT) as an active substance for use in 
biocidal products of product -type 10 in accordance with Regulation (EU) No 528/2012 of 
the European Parliament and of the Council  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the 
Council of 22 May 2012 concerning the making available on the market and use of biocidal 
products1, and in particular  Article 9(1), point (b), thereof,  
Whereas:  
(1) Pursuant to Article 11 (1) of Directive 98/8/EC  of the European Parliament and of the 
Council2, an application for approval of 1,2-benzisothiazol -3(2H) -one (BIT) for use in 
biocidal products of product -type 10 , masonry preservatives , as described in Annex V  
of that Directive , corre sponding to product -type 10 , construction material 
preservatives , as described in Annex V to Regulation (EU) No 528/2012 , was 
submitted to  the competent authority of Spain on 22 December 2009 .  
(2) Pursuant to Article 90( 2), first subparagraph,  of Regulation ( EU) No 528/2012, 
applications submitted for the purposes of Directive 98/8/EC for which the Member 
States’ evaluation in accordance with Article 11(2) of Directive 98/8/EC has not been 
completed by 1 September 2013 are to be evaluated by the competent auth orities in 
accordance with the provisions of th at Regulation . 
(3) On 1 October 2019, during the evaluation of the active substance  by the evaluating 
competent authority , the applicant withdrew its application  and no longer request s the 
approval of BIT as an active substance for use in biocidal products of product -type 10 . 
(4) BIT is not included for product -type 10 in Annex II to Commission Delegated 
Regulation (EU) No 1062/20143, which lists the active s ubstance/product -type 
combinatio ns included in the work programme for the examination of existing biocidal 
active substances contained in biocidal products . Biocidal products of product -type 10 
containing BIT are therefore not covered by the transitional provisions laid down in 
Article 8 9(2) of Regulation (EU) No 528/2012  and may therefore not be made 
available or used on the Union market.  
                                                 
1 OJ L 167, 27.6.2012,  p. 1.  
2 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the 
placing of biocidal products on the market (OJ L 123, 24.4.1998, p.1).  
3 Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for 
the systematic examination of all existing active substances contained in biocidal products referr ed to in 
Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 
1).  
EN 2  EN (5) However, i n accordance with the transitional provision set out in Article 94(1) , point 
(a), of Regulation (EU) No 528/2012 , a treated article treated with or intentionally 
incorporating one or more biocidal products containing only active substances that are 
under examination for the relevant product -type in the work programme referred to in 
Article 89(1) of that Regulation on 1 September 2016 or for wh ich an application for 
approval for the relevant product -type is submitted by that date, or containing only a 
combination of such substances and active substances included in the list drawn up in 
accordance with Article 9(2) of that Regulation for the rele vant product -type and use 
or included in Annex  I, may be placed on the market until the date falling 180 days 
after a decision not to approve one of the active substances for the relevant use, when 
such decision is adopted after 1 September 2016 . 
(6) As the ap plicant has withdrawn the application for approval of BIT for use in biocidal 
products of  product -type 10, there is no biocidal product to be evaluated. 
Consequently, the competent authority did not finalise the assessment report and the 
European Chemicals  Agency  did not prepare an opinion . Finally , as there is no 
biocidal product of product -type 10 containing BIT  that may be expected to meet the 
criteria laid down in Article 19(1), point (b),  of Regulation (EU) No 528/2012 , the 
conditions laid down in Arti cle 4(1) of that Regulation are not met. Considering also 
the need to ensure that treated articles treated with or intentionally incorporating BIT 
for product -type 10 are no longer placed on the Union market, it is appropriate not to 
approve BIT for use in  biocidal products of product -type 10.  
(7) The measures provided for in this Decision are in accordance with the opinion of the 
Standing Committee on Biocidal Products,  
HAS ADOPTED THIS DECISION:  
Article 1  
1,2-benzisothiazol -3(2H) -one (BIT ) (EC No: 220-120-9; CAS No: 2634 -33-5) is not approved 
as an active substance for use in biocidal products of product -type 10. 
Article 2 
This Decision shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN